MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; CATHETER, STEERABLE

Model Number	SGC0701
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4 degenerative mitral regurgitation (mr) flail leaflet for a mitraclip procedure.During the procedure, when clip was placed into the body, air bubbles were observed in the patient and guide had lost column.Guide was replaced and continued the procedure, and two mitraclips were implanted.The final mr was grade 1-2.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported leak (loss of fluid column).The air embolism appears to be related to the leak.Air embolism is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstances as no treatment was provided for the air embolism.There is no indication of a product issue with respect to manufacture, design, or labeling.Code 2199 was removed.

• Brand Name: MITRACLIP
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23950413
• Report Number: 2135147-2026-00024
• Device Sequence Number: 10757917
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025(17)260910(10)50313R1083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2026
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 50313R1083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown